Lead global regulatory submissions and ensure regulatory compliance for medical devices. Support QMS, audits (ISO, CE, MDSAP), risk management, clinical/biocompatibility activities, usability studies, and software V&V while advising senior management.
About EMED Technologies Corporation
About the role
- Regulatory Affairs Manager lead all aspects of Regulatory Affairs related to medical devices regulatory submissions and submissions for global markets, supports all aspects of the Quality Management System, design and development, and distribution. This position works with internal and external teams.
- The Regulatory Affairs Manager reports to the Director of CA/QA/RA.
What you'll do
- Act as backup for the Director of Quality and Regulatory Affairs and assist in audit activities (such as ISO, CE, MDSAP, California FDB).
- Lead and expedite submission processes to obtain regulatory clearances worldwide to support corporate goals.
- Ensure continued compliance with applicable local and international standards, regulations and laws related to the design, development, and distribution of medical devices.
- Build necessary relationships with internal and external stakeholders.
- Provide strategic advice to upper management to streamline global regulatory submissions and clearances.
- Maintain corporate awareness of relevant regulatory environment and notify relevant personnel of regulatory changes that may impact project or corporate strategic plans.
- Supports to maintain all applicable federal Facility Registrations and Listings, and State Licenses.
- Research and execute clinical validation activities relative to usability and post-market surveillance as well as improvement of existing and new devices.
- Perform and/or assist with human factors usability studies.
- Execute and/or assist with pre-clinical and clinical evaluations.
- Maintain regulatory compliance and certification of existing products.
- Supports the release of product to market.
- Perform Risk Management for new and existing products as required.
- Assist with Biological evaluations (Biocompatibility).
- Support Software Verification and Validation.
Qualifications
- Bachelor's degree with desired major areas including Law, Medicine, Pharmacy, Engineering, Science, or Manufacturing.
- 10+ years of experience in regulatory and clinical affairs, or equivalent functions for medical device, pharmaceutical, or healthcare industries.
- Experience organizing and leading meetings, communicating project progress, and ensuring actions are assigned/achieved.
- Extensive experience in quality assurance with a strong understanding of all MDSAP regulatory requirements, including ISO 13485, 21 CFR 820 (U.S. FDA), Brazil RDC ANVISA 16/2013 and RDC 23/2012, Japan MHLW Ordinance No. 169, Therapeutic Goods (Medical Devices) Regulations 2002 (Australia), and SOR/98-282 (Canada).
- Proven experience in managing audits (process, system, regulatory) and relationships with external constituencies.
- Proven interpersonal, written, verbal, and problem-solving skills, with the ability to communicate and work collaboratively.
- Basic MS Office skills.
- American Society for Quality CQA or CQE and/or RAPS RCA certification(s) highly desirable.
- Experience with risk management per ISO 14971.
- Experience and/or understanding of compliance to IEC 60601-1, IEC 62304, IEC 62366, EN 60601-2-24:2015 and IEC 62366-1 and -2.
Similar Jobs
Biotech • Pharmaceutical
Coordinate preparation, submission, and maintenance of global regulatory filings (INDs/CTAs, amendments, orphan drug applications, annual reports); prepare agency meeting briefs; lead responses to agency queries and track commitments; represent study-level regulatory activities on cross-functional teams; liaise with subject matter experts, CROs, and external authorities to ensure compliance with FDA and international regulations.
Biotech • Pharmaceutical
Support global regulatory strategy for oncology drug development by preparing and managing submissions (INDs/CTAs, orphan drug applications, annual reports), coordinating agency meetings and responses, tracking regulatory commitments, collaborating cross-functionally and with CROs, researching regulatory requirements, and maintaining compliance with US and international guidance.
Biotech • Pharmaceutical
Manage global regulatory activities for oncology drug development, including preparation and maintenance of INDs/CTAs and related submissions, agency meeting support, tracking/responding to regulatory queries and commitments, and representing study-level regulatory work on cross-functional teams.
What you need to know about the NYC Tech Scene
As the undisputed financial capital of the world, New York City is an epicenter of startup funding activity. The city has a thriving fintech scene and is a major player in verticals ranging from AI to biotech, cybersecurity and digital media. It also has universities like NYU, Columbia and Cornell Tech attracting students and researchers from across the globe, providing the ecosystem with a constant influx of world-class talent. And its East Coast location and three international airports make it a perfect spot for European companies establishing a foothold in the United States.
Key Facts About NYC Tech
- Number of Tech Workers: 549,200; 6% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Capgemini, Bloomberg, IBM, Spotify
- Key Industries: Artificial intelligence, Fintech
- Funding Landscape: $25.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Greycroft, Thrive Capital, Union Square Ventures, FirstMark Capital, Tiger Global Management, Tribeca Venture Partners, Insight Partners, Two Sigma Ventures
- Research Centers and Universities: Columbia University, New York University, Fordham University, CUNY, AI Now Institute, Flatiron Institute, C.N. Yang Institute for Theoretical Physics, NASA Space Radiation Laboratory
